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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, non-absorbable, orthopaedics, reinforcement of tendon
Definition For reinforcement of soft tissue where weakness exists in tendon repair.
Product CodeOWX
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ANIKA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

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